Senior Process Engineer - Aseptic Compliance & Validation

8562-Cilag AG Legal Entity; Schaffhausen; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Schaffhausen, Switzerland seeks a Compliance Engineer, Process Engineering (m/f). You will lead engineering and qualification activities, support validation of process equipment, and ensure GMP compliance across aseptic manufacturing environments.

The role requires strong problem solving, cross-functional collaboration, and experience in process equipment, automation, and change control within pharma/biotech settings.

Qualifikationen

• Extensive experience in process engineering and aseptic environments.
• Ability to troubleshoot complex process equipment and implement optimization.
• Proven track record in GMP/compliance and change control.

Aufgaben

• Lead engineering and qualification activities for process equipment, utilities and facilities.
• Support validation and qualification of systems in CM&T F2P2.
• Troubleshoot, document non-conformances, and coordinate with QA and production.
• Manage technical change and change control processes.
• Supervise technical order system with maintenance teams and service providers.
• Train staff on system and process-level procedures.
• Evaluate new tech platforms and assist in qualification for aseptic environments.
• Collaborate across engineering functions locally and globally.

Kenntnisse

Agile Decision Making

Coaching

Critical Thinking

Emerging Technologies

Engineering

Problem Solving

Process Control

Process Engineering

Process Improvements

Product Costing

Product Improvements

Research and Development

SAP Product Lifecycle Management

Situational Awareness

Technical Research

Technical Writing

Technologically Savvy

Vendor Selection

Tools

Automation Tools

Jobbeschreibung

Johnson & Johnson in Schaffhausen, Switzerland seeks a Compliance Engineer, Process Engineering (m/f). You will lead engineering and qualification activities, support validation of process equipment, and ensure GMP compliance across aseptic manufacturing environments.

The role requires strong problem solving, cross-functional collaboration, and experience in process equipment, automation, and change control within pharma/biotech settings.